MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 54X21X64 HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported patient enrolled in a (b)(4) study underwent initial right total shoulder arthroplasty on (b)(6) 2014.During post-operative monitoring and testing, the patient reported pain related to the procedure.There has been no reported revision procedure to date.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number (b)(4) states, "intraoperative or postoperative bone fracture and/or postoperative pain.".

Manufacturer Narrative

Additional information received indicates pain was noted to be unusual on adverse event form; however, pain onset was 13 days post-op.Pain is to be expected after initial procedure.Therefore, please disregard the report associated with this mfr number as there is no event to report.

• Brand Name: VERSA-DIAL 54X21X64 HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4802284
• MDR Text Key: 21473966
• Report Number: 0001825034-2015-02298
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 113063
• Device Lot Number: 882400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 118